It is known that digestive enzymes administered to mammals can remedy enzyme deficiency caused by aging or various diseased conditions, including those affecting the pancreas, such as cystic fibrosis, pancreatitis and pancreatic enzyme deficiency. Oral administration of supplemental digestive enzymes can be a solution. However, digestive enzymes produced by the pancreas are released into the duodenum, the pH of which is close to neutral or slightly alkaline. Under these pH conditions, these enzymes are active and digestion of the food by the enzymes proceeds normally in the upper segment of the intestine. However, when digestive enzymes are administered exogenously to the patient, the gastric conditions in the stomach, including the highly acidic environment therein, the presence of trypsin and pepsin, and, sometimes, interactions with other foods or stomach contents, will result in inactivating the enzymes (as a result of denaturation—i.e., a change in the enzyme's protein structure).
Such denaturation reactions have negatively inhibited wide-spread use of digestive enzyme supplements. Weakly formulated products are not effective, and not worth buying for the consumer, and more robust products (that allow some activity) sell at premium prices, and are often not affordable. Relatively low-cost formulations which permit digestive enzymes such as proteases, amylases, lipases and fiber digesting enzymes to be effectively delivered into the intestinal tract with reduced denaturation, offer increased effectiveness and enhanced market acceptance, permitting those suffering enzyme deficiencies the opportunity for treatment.